• Pituitary disorders

Saizen Generic Name & Formulations

General Description

Somatropin (rDNA origin) 5mg, 8.8mg; per vial; lyophilized pwd for SC inj after reconstitution; diluent contains benzyl alcohol.

Pharmacological Class

Growth hormone (GH).

How Supplied

Vial—1 (w. diluent); click.easy device—1 (8.8mg vial + diluent)


Saizen Indications


Treatment of children with growth failure due to GH deficiency. Adults with childhood-onset or adult-onset GH deficiency.

Saizen Dosage and Administration


Individualize. Rotate inj site. Give by SC inj. Weight-based regimen: initial max 0.005mg/kg per day; may increase after 4 weeks to max 0.01mg/kg per day. Non weight-based regimen: intially 0.2mg/day (range 0.15–0.3mg/day); may increase gradually every 1–2 months by increments of 0.1–0.2mg/day. Elderly or obese: may need lower dose.


Individualize. Rotate inj site. Give by SC inj. 0.18mg/kg per week divided into equal doses either on 3 alternate days, 6 times a week, or daily.

Saizen Contraindications


Acute critical illness. Active malignancy. Diabetic retinopathy. Children with closed epiphyses. Prader-Willi syndrome (severely obese or w. respiratory impairment); see full labeling.

Saizen Boxed Warnings

Not Applicable

Saizen Warnings/Precautions


Diabetes. Obesity. Turner syndrome. Monitor thyroid function, glucose tolerance, bone age, gait. Monitor for hip or knee pain, intracranial hypertension (do baseline and periodic funduscopic exams), and progression of scoliosis. Prader-Willi syndrome: evaluate baseline respiratory function; monitor weight and for respiratory infection. Discontinue if signs of upper airway obstruction or sleep apnea occur. Monitor for progression or recurrence in preexisting tumors. Hypopituitarism. Discontinue when epiphyses are fused. Elderly. Pregnancy (Cat.B). Nursing mothers.

Saizen Pharmacokinetics

See Literature

Saizen Interactions


May be antagonized by glucocorticoids. Concomitant oral estrogens: may require larger somatotropin doses. Antidiabetic medications may need to be adjusted. May affect CYP3A4 substrates. May increase phosphorus, alkaline phosphatase, PTH, IGF-1 serum levels.

Saizen Adverse Reactions

Adverse Reactions

Inj site reactions, fluid retention, peripheral edema, arthralgia, myalgia, paresthesia, headache; hypersensitivity (may be severe), hypoadrenalism, hypothyroidism; rare: pancreatitis. Long-term overdose may cause gigantism and/or acromegaly.

Saizen Clinical Trials

See Literature

Saizen Note


May be given using click.easy, a needle-free delivery device (see full labeling for instructions).

Saizen Patient Counseling

See Literature